- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00679991
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
April 8, 2015 updated by: Proteon Therapeutics
A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel.
The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Clarian Health Partners/Indiana University/Purdue University
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
-
-
Maine
-
Portland, Maine, United States, 04102
- Maine Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Springfield, Massachusetts, United States, 01104
- Western new England Renal & Transplant Associates
-
-
Missouri
-
St. Louis, Missouri, United States, 63110
- Washington University in St. Louis
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medical College
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Ohio
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Cincinnati, Ohio, United States, 45267
- University of Cincinnati Medical Center
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-
Texas
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Houston, Texas, United States, 77030
- The Methodist Hospital
-
-
Virginia
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Norfolk, Virginia, United States, 23507
- Sentara Medical Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age of at least 18 years.
- Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
- Planned creation of a new AVF.
Exclusion Criteria:
- Patients for whom this is the only potential site for an AVF.
- By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
- Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
- Pregnancy, lactation or plans to become pregnant during the course of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
Applied topically to AVF during surgery
Dose escalation study.
Drug/placebo administered at the time of fistula creation
|
Active Comparator: PRT-201
|
Applied topically to AVF during surgery
Dose escalation study.
Drug/placebo administered at the time of fistula creation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein.
Time Frame: 2 & 6 weeks after AVF creation
|
2 & 6 weeks after AVF creation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis.
Time Frame: 3, 6, 9, and 12 months
|
3, 6, 9, and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
May 15, 2008
First Submitted That Met QC Criteria
May 16, 2008
First Posted (Estimate)
May 19, 2008
Study Record Updates
Last Update Posted (Estimate)
April 30, 2015
Last Update Submitted That Met QC Criteria
April 8, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Congenital Abnormalities
- Renal Insufficiency
- Pathological Conditions, Anatomical
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Fistula
- Kidney Diseases
- Renal Insufficiency, Chronic
- Arteriovenous Fistula
Other Study ID Numbers
- PRT-201-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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